Tagtociclib (PF-07104091) Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 347

Clinical Trials

Multiple clinical trials sponsored by Pfizer are evaluating Tagtociclib (PF-07104091) across Phase 1 and Phase 2 studies. Early-stage trials assessing the drug's pharmacokinetic parameters and bioavailability in healthy adults have been completed. Additionally, trials evaluating safety, pharmacodynamics, and antitumor efficacy in patients with solid tumors, breast cancer, small cell lung cancer, and ovarian cancer are currently active but not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04553133	ACTIVE_NOT_RECRUITING	Small Cell Lung Cancer; Ovarian Cancer; Breast Cancer	Pfizer	2020-09-16	PHASE2
NCT05262400	ACTIVE_NOT_RECRUITING	Breast Cancer; Solid Tumors	Pfizer	2022-03-14	PHASE1; PHASE2
NCT07127770	COMPLETED	Healthy Adults	Pfizer	2025-08-28	PHASE1
NCT05431153	COMPLETED	Healthy	Pfizer	2022-06-10	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-06)

Check the Tagtociclib (PF-07104091) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tagtociclib (PF-07104091) selectively binds to and inhibits cyclin-dependent kinase 2 (CDK2), preventing downstream phosphorylation of key cell-cycle regulatory proteins and causing G1/S phase cell cycle arrest and apoptosis in tumor cells. This potent inhibition of cell proliferation provides the pharmacological rationale for its clinical evaluation in solid tumors, breast cancer, small cell lung cancer, and ovarian cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).